CarFlog
Molecular Characterisation and Clinical Implications of Inflammation Related to Peritoneal Carcinomatosis in Women With Ovarian or Colon Cancer.
Sponsor study identifier
observational
30
1 country
1
Study Start
March 1, 2017
Actual (reported)Primary Completion
June 1, 2018
Actual (reported)Study Completion
March 30, 2019
Actual (reported)Inflammation plays an important role in the pathogenesis of peritoneal carcinosis. Patients with elevated levels of different inflammation cytokines show a worse prognosis at the time of diagnosis. In women, ovarian and colon cancer are the main causes of peritoneal carcinosis and a comparison of these two different types of peritoneal invasion have not been conducted yet. We found interesting studying the role of immune response, in particular tumour-associated antigens (TAA) that modulate the metastatic process. We will investigate also mitochondrial defects, such as mutations in mt-DNA, potentially involved in carcinogenesis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2017
Actual (reported)June 1, 2018
Actual (reported)March 30, 2019
Actual (reported)October 9, 2019
Actual (reported)October 10, 2019
Actual (reported)Immune biomarkers level
Serum level of different immune related biomarkers (such as CD4, CD8, CUZD1, LAG3, PD1, PDL1, IMP1 and p62/IMP2) will be determined using ELISA.
Each patients will be assessed at baseline
Metastatic mediators level
Peritoneal expression of cytokines related to metastatic process (such as IL6, IL2, TNFα, TGFβ1, VEGF, CD68, FGFR1, CCL2/MCP-1, CD73) will be determined using real time-PCR.
Each patients will be assessed at baseline
P2X7R-inflammasome activity
Peritoneal expression of NLRP3-ASC will be determine using RT-PCR
Each patients will be assessed at baseline
Patients affected by ovarian cancer will be stratified according to BRCA1 and BRCA2 mutational status.
Patients affected by colon cancer will be similarly stratified according to BRAF and KRAS mutational status and to the presence of low-grade or high-grade microsatellite instability (MSI).
Partial removal of peritoneal tissue involved by neoplastic invasion
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The study consecutively enrolled 30 patients undergoing surgical treatment for peritoneal carcinosis: 15 patients affected by high grade ovarian cancer and 15 patients affected by colon cancer. Patients will be enrolled among those referring to the Gynaecologic Unit and the General Surgery Unit, University Hospital of Pisa, Italy.
University of Pisa
Pisa, 56125, Italy
peritoneal biopsy
Anna Solini, MD, PhD
University of Pisa
30 participants (actual enrollment reported by the registry).
First Submitted
October 9, 2019
First Posted
October 10, 2019
Study Start
March 1, 2017
Actual (reported)Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer
Contact the study team to confirm eligibility.
Primary Completion
June 1, 2018
Actual (reported)Study Completion
March 30, 2019
Actual (reported)Last Updated
November 25, 2019
Record last verified: 2019-11
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Source: ClinicalTrials.gov.
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